Translational Design of Medical Devices

描述（由申请人提供）：该资助支持UIC生物工程系最近推出的两个学期跨学科医疗产品开发（IMPD）高级设计顶级课程顺序，主要有两种方式：(1)开发生物医学临床浸入式课程，作为IMPD的入门课程；(2)获得熔融沉积建模快速原型机。拟议课程创新的两个互补方向将被整合：基于对用户需求的理解和欣赏的早期产品开发的真正跨学科教学，以及对医疗设备的先进原型和测试的迭代方法，以满足法规和标准。IMPD是模仿十年前在UIC开发的全国公认的跨学科产品开发（IPD）计划，从机械和工业工程开始。在IMPD，设计团队由生物工程专业的大四学生、工业设计专业的硕士学生和MBA学生组成，课程由来自所有三个学院（工程、建筑与设计和商业）的教师共同教授。IMPD受益于分配给每个团队的临床医生导师的频繁反馈，这些导师是根据项目主题选择的。此外，该项目由行业合作伙伴赞助，该合作伙伴为每个团队提供行业视角的指导。IMPD项目让学生接触到整个医疗产品开发周期，从需求评估的最早阶段开始。IMPD课程确实提供临床观察并从早期阶段开始参与临床投入；但是，生物医学临床浸入式课程将提供深度，以全面了解临床环境，包括流程，变通方法和低效率。概念验证测试位于产品开发周期的另一端，并且必须依赖于物理原型。迭代原型的过程允许对概念进行细化，使其在外观、感觉和功能上都合适。获得熔融沉积建模快速原型机将允许学生快速实现和响应他们基于cad的概念设计，并允许他们在尽可能“真实世界”的场景中体验整个产品开发周期。

DESCRIPTION (provided by applicant): This grant supports the enhancement of a recently launched two semester Interdisciplinary Medical Product Development (IMPD) senior design capstone course sequence in the Department of Bioengineering at UIC in two significant ways: (1) development of a Biomedical Clinical Immersion course to serve as a gateway to IMPD, and (2) acquisition of a Fused Deposition Modeling rapid prototype machine. Two complementary directions of proposed curricular innovation will be integrated: a truly interdisciplinary teachingof early product development that is based on an understanding and appreciation of user needs, and an iterative approach to advanced prototyping and testing of medical devices to meet regulations and standards. IMPD is modeled on the nationally recognized Interdisciplinary Product Development (IPD) program developed at UIC a decade ago starting with mechanical and industrial engineering. In IMPD, design teams are comprised of seniors in Bioengineering, MFA Industrial Design students, and MBA students, and the course is co-taught by faculty from all three colleges (Engineering, Architecture and Design, and Business). IMPD benefits from frequent feedback from clinician mentors assigned to each team that are selected based upon the project topic. In addition, the project is sponsored by an industry partner, which provides industry-perspective mentorship to each team. The IMPD program exposes students to the entire medical product development cycle, beginning in the earliest stages of needs assessment. The IMPD course does provide for clinical observation and engaging clinical input from the earliest stages; but, a Biomedical Clinical Immersion course will provide the depth to holistically understand the clinical environment, including process flow, workarounds, and inefficiencies. Proof of concept testing lies at the opposite end of the product development cycle, and necessarily relies upon a physical prototype. The process of iterative prototyping permits refinement of the concept such that it is appropriate in look, feel and function. Acquisition of a Fused Deposition Modeling rapid prototype machine will permit students to quickly actualize and respond to their CAD-based concept designs, and allow them to experience the entirety of the product development cycle in as "real world" scenario as possible.